(116 days)
Not Found
No
The 510(k) summary describes a mechanical endoscopic clipping device and its intended uses. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The performance studies focus on mechanical properties and substantial equivalence to a predicate device, not algorithmic performance.
Yes
The device is indicated for purposes such as hemostasis and closure of gastrointestinal tract luminal perforations, which are therapeutic actions.
No
The device is indicated for therapeutic purposes such as endoscopic marking, hemostasis, and closure of GI tract luminal perforations, not for diagnosing conditions.
No
The device description explicitly states it consists of "two main components, delivery system and clip assembly," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for endoscopic clip placement within the gastrointestinal tract for purposes like marking, hemostasis, and closure of perforations. These are all therapeutic or procedural actions performed directly on the patient's body.
- Device Description: The description confirms it's an endoscopic clipping device used for these procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for direct intervention.
N/A
Intended Use / Indications for Use
The Single Use MultiClip Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
(1) endoscopic marking,
(2) hemostasis for
(a) mucosal / sub-mucosal defects
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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June 1, 2018
Micro-Tech (Nanjing) CO., Ltd. Becky Li Ouality and Regulatory Affairs Director NO. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China
Re: K180325
Trade/Device Name: Single Use MultiClip Device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: April 19, 2018 Received: April 23, 2018
Dear Becky Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Single Use MultiClip Device
Indications for Use (Describe)
The Single Use MultiClip Device is indicated for endoscopic clip placement within the
gastrointestinal tract for the purpose of:
(1) endoscopic marking,
(2) hemostasis for
(a) mucosal / sub-mucosal defects Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Tab 7
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K180325
1. Date of Preparation: 2018-05-30
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone,
Nanjing, Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Becky Li
Position: Quality and Regulatory Affairs Director
Tel: +86-25-58646378
Fax: +86-25-58350006
Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Trade Name: Single Use MultiClip Device
Common Name: Hemostasis Clipping Device
Regulatory Information
Classification Name: Hemorrhoidal ligator
Classification: 2
Product Code: PKL
Regulation Number: 876.4400
Review Panel: Gastroenterology/Urology
Intended Use Statement:
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This device is intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract.
4. Identification of Predicate Device
510(k) Number: K152001
Product Name: Sterile Repositionable Hemostasis Clipping Device
5. Indications for Use
The Single Use MultiClip Device is indicated for endoscopic clip placement within
the gastrointestinal tract for the purpose of:
- (1) endoscopic marking,
- (2) hemostasis for
- (a) mucosal / sub-mucosal defects Sterility tests,
ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on medical devices in the magnetic resonance environment. (Materials) ,
ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants , and
ASTM F2182 - 11a Standard Test Method for Measurement of Radio Frequency
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Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging.
The following bench tests were performed on the Single Use MultiClip Device
| Dimensional verification | Mechanical Integrity of Clip Assembly |
|---|---|
| Clamping Strength Testing | Tensile Strength Testing |
| Release Force Testing | Rotation Testing |
| Multiple Clip Deployment Testing | Reposition Testing |
The proposed device has 3 or 5 clips, the 3 or 5 clips could be continuous released by the delivery system, the model with 5 clips as the worst case to do the bench tests, each clip in the 5 clips has done the related bench tests, and conduct the substantially equivalent analysis to the predicate device The testing performed demonstrated that the proposed device and predicate device are substantially equivalent.
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Single Use MultiClip Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the Sterile Repositionable Hemostasis Clipping Device (K152001).